Treatment of Zollinger-Ellison Syndrome With Prevacid

• Sponsor: Charles Mel Wilcox, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00204373
• Collaborator: Takeda Pharmaceuticals North America, Inc. (Industry)
• Enrollment: 72
• Arm: 1
• Duration (Months): 93

Study Details

Study Description

Brief Summary

The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.

Condition or Disease	Intervention/Treatment	Phase
Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia	Drug: Lansoprazole (Prevacid)	Phase 4

Detailed Description

The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observation of the efficacy in controlling gastric acid production and of the safety of high dose, long-term use of Prevacid.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single group This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.	Drug: Lansoprazole (Prevacid); Lansoprazole 30mg capsules. dose is individualized to each subject based on gastric acid production. The range is 30 mg to 450 mg daily.; Other Names: Lansoprazole is marketed as Prevacid.

Outcome Measures

Primary Outcome Measures

1. Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment. [up to 240 months from study enrollment]

   number of participants with control of gastric acid production

Secondary Outcome Measures

1. The Median Survival From the Time of Diagnosis. [survival or up to 240 months]

   The median survival from the time of diagnosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with Zollinger-Ellison syndrome

Exclusion Criteria:

• Pregnant or lactating females

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Charles Mel Wilcox, MD
• Takeda Pharmaceuticals North America, Inc.

Investigators

• Principal Investigator: C. Mel Wilcox, M.D., University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Charles Mel Wilcox, MD, Prinicle Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00204373
• Other Study ID Numbers: F030107005
• First Posted: Sep 20, 2005
• Last Update Posted: Oct 30, 2012
• Last Verified: Oct 1, 2012

• Additional relevant MeSH terms: Endocrine Gland Neoplasms; Multiple Endocrine Neoplasia; Zollinger-Ellison Syndrome; Gastrinoma; Syndrome; Lansoprazole; Dexlansoprazole

Study Results

Participant Flow

Recruitment Details	Patients were recruited from the GI/Hepatology clinic located at The Kirklin Clinic. Patients were referred here from their primary care physician or chose this clinic through self-referral for care for a GI issue. Patients were recruited between early 2003 and early 2010.
Pre-assignment Detail	The first phase of this study involved a short-term dose determination phase followed by a long-term treatment phase.

Arm/Group Title	Single Group
Arm/Group Description	This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Period Title: Overall Study
STARTED	72
COMPLETED	72
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Single Group
Arm/Group Description	This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Overall Participants	72
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	68 94.4%
>=65 years	4 5.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54 (11.6)
Sex: Female, Male (Count of Participants)
Female	30 41.7%
Male	42 58.3%
Region of Enrollment (participants) [Number]
United States	72 100%

Outcome Measures

1. Primary Outcome

Title	Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
Description	number of participants with control of gastric acid production
Time Frame	up to 240 months from study enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Group
Arm/Group Description	This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Measure Participants	72
Number [participants]	72 100%

2. Secondary Outcome

Title	The Median Survival From the Time of Diagnosis.
Description	The median survival from the time of diagnosis
Time Frame	survival or up to 240 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Single Group
Arm/Group Description	This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
Measure Participants	72
Median (Standard Deviation) [years]	6.6 (1.8)

Adverse Events

Arm/Group Title	Single Group
Arm/Group Description	This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
All Cause Mortality
	Single Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Single Group
	Affected / at Risk (%)	# Events
Total	28/72 (38.9%)
Cardiac disorders
Death	9/72 (12.5%)	9
Gastrointestinal disorders
Mucosal relapse	12/72 (16.7%)	12
Cancer	5/72 (6.9%)	5
Death (metastatic gastrinoma)	2/72 (2.8%)	2
Other (Not Including Serious) Adverse Events
	Single Group
	Affected / at Risk (%)	# Events
Total	21/72 (29.2%)
Gastrointestinal disorders
Nausea and vomiting	13/72 (18.1%)	13
Musculoskeletal and connective tissue disorders
Leg Pain	4/72 (5.6%)	4
Respiratory, thoracic and mediastinal disorders
Pneumonia	4/72 (5.6%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.